Catheter-based heart support system and method of implanting thereof

ABSTRACT

A circulatory support device for an in-vivo heard includes a pump-holder that is placed in an outflow tract of the heart. The pump-holder includes an anchor that is placed in the subcommissural triangles underneath the aortic valve or the pulmonary valve of the heart in a blood flow direction. The device also includes a pump that is placed in the pump-holder. The pump may be placed in the pump holder after the pump-holder is placed in the subcommissural triangles. Once in place, the circulatory support device does not extend through the aortic valve or the pulmonary valve.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a national state application of PCT/US2014/036018,filed Apr. 30, 2014, which claims the benefit of priority from GermanApplication DE 102013208038.7, filed May 2, 2013. This application isalso related to, as the parent, of U.S. application Ser. No. 14/991,365,filed Jan. 8, 2016 and now U.S. Pat. No. 9,744,281, issued Aug. 29,2017. The contents of all three of these applications are incorporatedherein by reference.

BACKGROUND

The invention relates to a catheter-based heart support system orcatheter-based heart assist system and in particular, to a device forcirculatory support of the heart, an electrical supply line or driveline for said device and a system for handling said device and a methodof implanting the system in the heart and a method for handling and foradjusting the position of the system.

US 2010/0249489 A1 describes an intraventricular blood pump which can beanchored in the aorta by a fixing means and can project into the leftventricle of the heart of a patient, wherein, the fixing means is fixedin the direction of blood flow in the aorta (i.e. not in the heart, onthe aortic side of the aortic valve). The pump is “hung” on the fixingmeans, wherein the outlet opening is arranged closely adjacent to andabove the aortic valve and the fixing means projects through the aorticvalve when said pump is implanted. In a further embodiment, the fixingmeans comprises an expandable stent, which can be fixed above the aorticvalve in the flow direction of the blood downstream of the aortic valve.In a further embodiment, a valve prosthesis is arranged at the fixingmeans, wherein, when the pump is implanted, one end of said valveprosthesis is connected to the outlet opening of the pump and the otherend of said valve prosthesis ends in the aorta spaced from the aorticvalve. US 2010/0249489 A1 suggests to implant said pump usingnon-invasive surgery, wherein the pump can be inserted through anopening at the apex of the left ventricle of the heart by means of acatheter. An electrical supply line, which is connected to the pump, isguided through this opening to the outside of the body of a patient. Asan alternative, it is suggested that the electrical supply line isguided to the outside via the aorta, wherein in said case the pumpshould be inserted by means of a catheter system through the aorta.

US 2006/0195004 A1 relates to a blood pump which can be implanted in thearea of the aortic valve of the heart of a patient, wherein a part ofthe device should be supported in the outflow tract of the ventricularspace adjacent to the aortic valve. In the implanted state, two of thethree aortic valve leaflets should retain their natural function, whilethe pump is arranged in the area of the third aortic valve leaflet.

SUMMARY

It is an object of the present invention to provide a device forcirculatory support of the heart as well as an electrical supply linefor said device and a system for handling said device and a method ofimplanting the system in the heart and a method for handling and foradjusting the position of the system.

This object is achieved by the features of the independent claims. Thedependent claims relate to preferred embodiments of the invention.

The present invention starts out from the basic idea to provide a devicewhich comprises a pump and a holding means and is configured andstructured such that it can be implanted in the left or rightventricular outflow tract of the heart. Furthermore, this device can beimplanted in the left or right ventricular outflow tract of the heart insuch a manner that the heart retains its natural function and is notadversely affected by the device when the device is implanted.

In accordance with an aspect of the invention, the device forcirculatory support of the heart comprises a holding means which isconfigured such that it can be implanted intracardially in the outflowtract of the left and/or right ventricle of the heart by means of acatheter. Thus, one device can be implanted in either one of the left orright ventricle or two devices can be implanted, one in the leftventricle and another one in the right ventricle. The device and/or theholding means is preferably configured such that it can be implanted inthe left or right ventricular outflow tract of the heart by means of acatheter, using an endovascular method, through a femoral access orthrough a percutaneous transapical access or a combination of bothaccesses. According to a further aspect the holding means is configuredsuch that it can be implanted in the sub-valvular position of the outletvalve of the respective ventricle, just underneath the aortic orpulmonary valve on the ventricular side.

In accordance with an aspect of the invention, the device forcirculatory support of the heart comprises a holding means which isconfigured such that it can be implanted in the left ventricular outflowtract of the heart by means of a catheter. The holding means ispreferably configured such that it can be implanted in the leftventricular outflow tract of the heart by means of a catheter, using anendovascular method, through a femoral access or through a percutaneoustransapical access or a combination of both accesses. The holding meanscomprises anchoring means which can be fixed in the subcommissuraltriangle underneath the aortic valve in the flow direction of the bloodon the ventricular side of the aortic valve.

In accordance with another aspect of the invention, the device forcirculatory support of the heart comprises a holding means which isconfigured such that it can be implanted in the right ventricularoutflow tract of the heart by means of a catheter. The holding means ispreferably configured such that it can be implanted in the rightventricular outflow tract of the heart by means of a catheter, using anendovascular method, through a femoral access or through a percutaneoustransapical access or a combination of both accesses. The holding meanscomprises anchoring means which can be fixed in the subcommissuraltriangle underneath the pulmonary valve in the flow direction of theblood on the ventricular side of the pulmonary valve.

In the following description reference is made to implanting the devicein either the left or the right ventricle. The description withreference to the left ventricle similarly applies to the case where thedevice is implanted in the right ventricle and vice versa.

The device for circulatory support of the heart moreover comprises apump which is configured such that it can be fixed in the holding meansby means of a catheter. The pump is preferably configured such that itcan be fixed in the holding means by means of the catheter, using anendovascular method, through a femoral access and/or through apercutaneous transapical access.

According to a further aspect of the invention, the pump and the holdingmeans are configured such that the pump can be inserted releasably inthe holding means after the holding means has been fixed by theanchoring means in the subcommissural triangles underneath the aorticvalve.

According to an alternative aspect of the invention, the pump and theholding means are configured such that the pump is firmly arranged inthe holding means and they can be implanted together by means of acatheter in the left or right ventricular outflow tract of the heart,wherein the holding means can be fixed by the anchoring means in thesubcommissural triangle underneath the aortic valve in the flowdirection of the blood upstream of the aortic valve.

According to a further aspect of the invention, the holding means and/orthe anchoring means is/are collapsible so that it/they can be implantedby means of the catheter. More preferably, the holding means and/or theanchoring means is/are expandable, preferably self-expandable, so thatthe anchoring means can be anchored in the subcommissural triangleunderneath the aortic valve.

According to a further aspect of the invention, the anchoring meanscomprises at least one expandable stent, which can be expanded by meansof a balloon or which is preferably configured such that it generates aself-expanding force which can cause anchorage in the fibrous tissue inthe subcommissural triangles of the left or right heart ventricle.Preferably, the expandable stent has at least one hook by means of whichthe stent causes anchorage in the fibrous tissue in the subcommissuraltriangles of the left or right heart ventricle.

According to another aspect of the invention, the pump comprises anelectric motor and a blade connectable thereto, wherein in the implantedstate of the pump, the motor rotates the blade such that blood can bepumped from the left heart ventricle in the direction of the aorticvalve or from the right heart ventricle in the direction of thepulmonary valve.

According to a further aspect of the invention, the electric motorcomprises first means forming the stator and being arranged at the stentand second means forming the rotor and being arranged centrally insidethe first means, wherein the first means are collapsible and expandable.

Preferably, the first means form the stator coils of the electric motor.Also preferably, the second means form the rotor with permanent magnetsof the electric motor.

According to a further aspect of the invention, the first means compriseelectrical coils and the second means of the electric motor comprisepermanent magnets. Alternatively, the first means comprise permanentmagnets and the second means of the electric motor comprise electricalcoils. The electrical coils can be connected to a power supply apparatusby means of a supply line.

According to an alternative aspect of the invention, the pump comprisesan electric motor comprising flexible suspension means which arecollapsible for implantation and by means of which the electric motorcan be releasably inserted at the anchoring means, preferably the stent.The electric motor can be connected to a power supply apparatus by meansof a supply line.

According to a further alternative embodiment, the pump comprises arotational shaft at which at least one blade is arranged, wherein theblade is collapsible for implanting the pump and configured such that itis rotatable with the rotational shaft in the mounted state of the pumpand automatically straightens up and/or can be straightened up in anoperating position, and during operation of the pump blood can be pumpedin the direction of the aortic valve.

According to a further embodiment, the pump is a rotary blood pump,preferably an axial flow pump or a centrifugal pump. The rotary bloodpump is firmly arranged in the holding means. The rotary blood pump ispreferably attached to the anchoring means or anchoring stent which isarranged on the ventricular side of the aortic valve in the leftventricular outflow tract or the ventricular side of the pulmonary valvein the right ventricular outflow tract. The rotary blood pump pumps theblood from the left ventricle across the aortic valve in the systemiccirculation, when implanted in the left ventricle. Similarly, the rotaryblood pump pumps the blood from the right ventricle across the pulmonaryvalve in the pulmonary circulation, when implanted in the rightventricle.

According to an aspect of the invention, an electrical supply line isconfigured such that it connects the circulatory support device, whichcan be implanted in the left ventricular outflow tract of the heart, toa power source and/or a control apparatus. The electrical supply line ispreferably configured such that it can be pulled out of the heart bymeans of a guide wire and can seal the opening in the heart for thepercutaneously placed guide wire.

According to an aspect of the invention, the electrical supply line isconfigured such that it can be guided from the left ventricle of theheart through the apex of the left ventricle of the heart and preferablyfurther to a site at the skin surface of a patient.

According to an alternative embodiment, the electrical supply line isconfigured such that it can be guided from the left ventricle of theheart through the lateral wall of the left ventricle or through thelower wall of the left ventricle and preferably further to a site at theskin surface of a patient.

According to a further embodiment, the electrical supply line isconfigured such that it extends in the cardiac septum up to the apex ofthe heart or to the front or the rear outer wall of the septum and canpreferably be guided further to a site at the skin surface of a patient.

According to yet a further embodiment of the invention, the electricalsupply line is configured such that it can be guided from the leftventricle of the heart through the cardiac septum in the right ventricleand then further through the free wall of the right ventricle andpreferably further to a site at the skin surface of a patient.

According to yet a further embodiment of the invention, the electricalsupply line is configured such that it can be guided from the leftventricle of the heart through the cardiac septum into the rightventricle and then further into the right atrium, then transvenously viaa large vena cava out of a large peripheral vein (e.g. subclavian vein,jugular vein, axillary or femoral vein) preferably further to a site atthe skin surface of a patient.

According to yet a further embodiment of the invention, the electricalsupply line is configured such that it can be guided from the leftventricle of the heart to the left atrium through the interatrial septuminto the right atrium, then transvenously via a large vena cava out of alarge peripheral vein (e.g. subclavian vein, jugular vein, axillary orfemoral veins) preferably further to a site at the skin surface of apatient.

An aspect of the invention relates to a system for handling the devicefor circulatory support of the heart and the supply line, in particularfor implanting the device and the supply line and/or for removing thedevice and the supply line and/or for newly positioning or adjusting thedevice and the supply line. The system preferably comprises a cathetermeans for implanting the device and for newly positioning or adjustingthe device in the left ventricle of the heart of a patient.

According to an aspect of the invention, the second catheter meanscomprises a guide wire which is configured such that it can be used forpulling the supply line out of the heart, wherein the electrical supplyline seals the opening in the heart of the preferably percutaneouslyplaced guide wire.

According to an aspect of the invention, the preferably percutaneouslyplaced guide wire is configured such that it can be used for pulling theelectrical supply line through the apex or the lateral or lower wall ofthe left ventricle out of the heart, and the opening for thepercutaneously placed guide wire can be sealed.

According to a further aspect of the invention, the preferablypercutaneously placed guide wire is configured such that it can be usedfor pulling the electrical supply line in the cardiac septum out of theheart, and the opening for the percutaneously placed guide wire can besealed.

According to a further alternative embodiment, the preferablypercutaneously placed guide wire is configured such that the electricalsupply line can be pulled through the cardiac septum into the rightventricle and then through the free wall of the right ventricle out ofthe heart, and the opening for the percutaneously placed guide wire canbe sealed.

According to a further alternative embodiment, the preferablypercutaneously placed guide wire is configured such that the electricalsupply line can be pulled through the cardiac septum into the rightventricle and then through the right atrium transvenously via the largevena cava out of a large peripheral vein (e.g. the subclavian vein,jugular vein, axillary or femoral veins), and the opening for thepercutaneously placed guide wire can be sealed.

According to a further alternative embodiment, the preferablypercutaneously placed guide wire is configured such that the electricalsupply line can be pulled from the left ventricle to the left atriumthrough the atrial septum into the right atrium transvenously via alarge vena cava out of a large peripheral vein (e.g. subclavian vein,jugular vein, axillary or femoral veins), and the opening for thepercutaneously placed guide wire can be sealed.

In accordance with a further aspect of the invention, a connector isdescribed, in particular a plug-in connector for an electrical supplyline. The connector is configured for being arranged in the subcutaneoustissue of a patient and for providing a releasable electrical connectionbetween an implanted part of an electrical supply line and a part of theelectrical supply line being directed outwardly.

The connector is preferably provided in the subcutaneous tissue. In caseof an infection or would healing disorder at the exit site of thecontrol line, it is thus not necessary to replace the entire system butit is sufficient to provide a new control line and connect it by meansof the new subcutaneous plug-in connector to the heart support system.Upcoming infections can thus be prevented.

Application in the subcommissural triangle has considerable advantagesvis-à-vis the prior art. On the one hand, in this position no inletcannula of the heart support system is necessary. In accordance with thepresent prior art, inlet cannulae are associated with most of thethrombo-embolic complications. Because of its position, the presentinvention does not need an inlet port and is advantageous in that theblood on the inlet side of the pump does not come in contact with aforeign surface or only to a much lesser extent than in conventionalheart support systems.

The attachment below the aortic valve and pulmonary valve, respectivelyhas not yet been described in the prior art because the anatomicalanchoring of a stent in this position is difficult to imagine to anon-heart surgeon and requires an exact knowledge of the anatomy of theheart. This fixing method has not yet been taken into consideration.

It is a disadvantage of systems, which pump the blood within thearterial system that, starting from a certain pumping power on the sideof the inlet cannula, where the blood is sucked, a “steal phenomenon”appears. The latter is caused in that a negative or reduced arterialpressure is created at the inlet cannula, which can reduce the bloodflow to arterial side branches in the area of the inlet cannula. Areduced coronary flow occurs in the ascending aorta starting from acertain flow rate, which might cause a coronary ischemia with allpossible consequences such as arrhythmia, deterioration of the diastolicand systolic heart insufficiency and myocardial infarction. When beingpositioned downstream of the head vessels, such a configuration canadditionally also cause a cerebral ischemia. When arranging the heartsupport system below the aortic valve in accordance with the presentinvention, such a “steal phenomenon” is prevented because thecoronaries, the first branches of the arterial system, lie directlyabove the aortic valve, i.e. in the outflow tract of the heart assistsystem. As the pumping power increases, there is only an increasedemptying of the left or right heart ventricle and an increased bloodflow in the arterial system.

Systems traversing the aortic valve are disadvantageous in that either abiological valve is required or a foreign body comes in contact with theaortic valve at any heart cycle, which in the long term might lead to avalve degeneration. Biological valves used in heart support systems havea relatively short lifetime and, e.g., in the rematch trial had been oneof the main reasons, which led to a failure of the device in theHeartmate system after one to two years. The present invention isadvantageous in that the native aortic valve of the patient is leftuntouched, is not always exposed to mechanical forces, which arenormally not present, and can continue its function. There are nobiological or artificial valves, which combine all advantages of anative heart valve.

The optional collapsible embodiment of the present invention alsorequires larger distances between the rotor and the stator thanconventional rotary blood pumps. This necessarily leads to a lessefficient pump, which despite rotor optimization cannot overcome asystematic pressure gradient. Such a pump configuration thus is evenmore sensitive to afterload than the systems nowadays used. Only byproviding the pump on the ventricular side of the aortic valve can sucha pump configuration function. With a pressure gradient of 20 mm Hg, thepresent invention can pump about 20 liters per minute, which means thatin a heart support system of the heart, about 6 liters per minute arepumped during the systole, which is sufficient for a cardiac assistdevice.

Our invention also allows to anchor a conventional small rotary bloodpump, preferably an axial flow pump or a centrifugal flow pump by meansof the stent in the left ventricular outflow tract or in the rightventricular outflow tract, more specifically to anchor the stent in thefibrous tissue in the subcommissural triangles adjacent to the aortic orpulmonary valve.

It is a further advantage that in case of an interruption of theoperation of the system, the physiology of an acute massive aortic valveinsufficiency does not occur. Today's heart support systems aredisadvantageous in that in case of power interruptions, which occur inalmost all patients using heart support systems for a long time, canlead to an acute massive deterioration.

Furthermore, the device of the present invention is positioned in a zoneof the heart which has relatively little stasis of the blood, contraryto the apex of the ventricle and the atrium. It is therefore conceivablethat this configuration is less sensitive to thrombo-emboliccomplications because of the high wash-out of the system.

The holding means of the present invention extends into the left (orright) ventricular outflow tract. This has the advantage that inaddition to the anchoring directly under the aortic valve, it keeps theblood flow to the device open and prevents collapse and sucking-in ofintraventricular structures and sucking-in of the front mitral valveleaflet (or tricuspid valve). The holding means is implanted into theleft ventricular outflow tract, where it has no anchoring function butguarantees the flow to the rotor. Even at a physiological pumping powerof 4 to 5 liters per minute, the front leaflet of the mitral valve willnot be sucked into the left ventricular outflow tract and will not havea negative effect on the emptying of the ventricle and the function ofthe pump.

The described electrical line, which is guided via a guide wire andseals the apex of the heart, is advantageous in that it does not requirea surgical access.

One further aspect of the invention relates to a minimally invasivemethod to implant a left and/or right ventricular assist device in asub-valvular position of the outlet valve of the respective ventricle,i.e. just underneath the aortic or pulmonary valve using holding means,preferably a stented anchoring device (as shown for example in FIG. 1).The holding means holds a preferentially rotary blood pump in positionto allow circulatory support of the heart. The method entails insertinga relatively large device through a large artery or vein or directlythough the heart and bringing it to the sub-valvular position of theheart for circulatory support.

A further aspect of the invention relates to a method of assist deviceimplantation of said device using endovascular over-the-wire techniques.It entails access to the vascular system or directly the heart at one ortwo separate points to allow control of a guide wire at both ends(“tooth-floss technique”, see for example FIG. 9), which allows precisedevice control for exact deployment at the desired landing point in thesub-valvular position.

This method also entails adjusting and correcting of the device positionwith traction on the wires in opposite directions, if needed. Tractionon both ends of the wires allows partial collapse of the device (see forexample FIG. 17).

Still another aspect of the invention relates to a method that entailssealing and hemostasis of the access puncture site of the heart orvascular system after device deployment. The sealing and hemostasis isaccomplished with a driveline, which has a larger diameter than theaccess catheter used for the procedure. This driveline serves to sealthe access site and is pulled out over a wire and will subsequently sealthe vascular/cardiac access site. This method preferably uses adriveline that has one or more longitudinal wire channels. The drivelinepreferably has a configuration with a diameter that is designed in sucha fashion, that bleeding at the puncture site is prevented by pullingthe driveline outside the puncture site in the heart or a blood vesselover the guide wire. The driveline preferably comprises a surfacecoating that prevents bleeding at the puncture site.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, the invention will be explained in more detail on thebasis of embodiments and the drawings, wherein:

FIG. 1 shows a schematic view of a first embodiment of the invention,which is arranged in the left ventricular outflow tract of the heart andwherein the device is anchored in the subcommissural triangles,

FIG. 2 shows a schematic view of a second embodiment of the invention,in which a self-expanding minimally invasively introducible stent graftor metal frame is arranged in the left ventricular outflow tract,

FIG. 3 shows a schematic view of a third embodiment of the invention, inwhich a self-expanding minimally invasively introducible stentgraft/metal frame is arranged in the left ventricular outflow tract,

FIG. 4 shows a schematic view of a fourth embodiment of the invention,in which a self-expanding minimally invasively introducible stentgraft/metal frame is arranged in the left ventricular outflow tract,

FIG. 5 shows a schematic view of a fifth embodiment of the invention, inwhich a self-expanding minimally invasively introducible stentgraft/metal frame is arranged in the left ventricular outflow tract,

FIG. 6 shows a schematic view of a sixth embodiment of the invention, inwhich a self-expanding minimally invasively introducible stentgraft/metal frame is arranged in the left ventricular outflow tract,

FIG. 7 shows a schematic view of a seventh embodiment of the invention,in which a self-expanding minimally invasively introducible stentgraft/metal frame is arranged in the left ventricular outflow tract,

FIG. 8 shows a schematic view of an eighth embodiment of the invention,in which a self-expanding minimally invasively introducible stentgraft/metal frame is arranged in the left ventricular outflow tract,

FIG. 9 shows a schematic view of a first embodiment of a systemaccording to the invention for handling the device according to theinvention,

FIG. 10a shows a side view of a ninth embodiment of the device accordingto the invention,

FIG. 10b shows a top view of the ninth embodiment with built-in rotor,

FIG. 10c shows a top view of the ninth embodiment of FIG. 10b withoutrotor,

FIG. 10d shows a detailed view of the ninth embodiment of FIG. 10a ,wherein a part of the holding means has been omitted,

FIG. 10e shows a schematic top view of a stator which is integrated inthe ninth embodiment,

FIGS. 11a, 11b and 11c show schematic views of a first embodiment of arotor with foldable rotor blades, wherein FIG. 11a shows the rotor in aflexible tubular insertion instrument, FIG. 11b shows the rotor in thesemi-unfolded state of the rotor blade, and FIG. 11c shows the rotorwith completely unfolded rotor blades,

FIGS. 12a, 12b and 12c show schematic views of a second embodiment of arotor with foldable rotor blades, wherein FIG. 12a shows the rotor in aflexible tubular insertion instrument, FIG. 12b shows the rotor in thesemi-unfolded state of the rotor blade, and FIG. 12c shows the rotorwith completely unfolded rotor blades,

FIG. 13a shows a schematic developed view for anatomically describingthe left ventricular outflow tract and the site where the deviceaccording to the invention is arranged,

FIG. 13b shows a schematic developed view for anatomically describingthe left ventricular outflow tract and for explaining the site where thedevice according to the invention is arranged,

FIG. 13c shows a schematic view of the aortic root anatomy forexplaining in more detail the position of the sub-commissural triangles,

FIG. 14 shows a schematic view of a cross-section through the membranousseptum for anatomically describing the front part of the leftventricular outflow tract and for explaining the site where the deviceaccording to the invention is arranged,

FIG. 15a shows a schematic view of a further embodiment, wherein theparts lying inside the body of a patient are visible,

FIG. 15b shows a schematic view of a further embodiment, wherein theparts lying inside the body of a patient are not visible,

FIG. 16a shows an enlarged schematic view of a first embodiment of aplug-in connector for a supply line of the device according to theinvention, wherein the plug and the coupling are disconnected from eachother,

FIG. 16b shows an enlarged schematic view of a first embodiment of aplug-in connector for a supply line of the device according to theinvention, wherein the plug is connected to the coupling,

FIG. 17a shows an enlarged schematic view of a further embodiment forhandling and in particular for repositioning the device according to theinvention, wherein the stent graft/metal frame has a first, relativelylarge diameter,

FIG. 17b shows an enlarged schematic view of a further embodiment forhandling and in particular for repositioning the device according to theinvention, wherein the stent graft/metal frame has a second, relativelysmall diameter,

FIG. 18 shows a schematic view of an embodiment of the invention,wherein the device is arranged in the right ventricular outflow tract ofthe heart, and

FIG. 19a shows a schematic view of an embodiment of the invention, wherea small rotary pump, for example an axial flow pump or a centrifugalpump, is secured to the left ventricular outflow tract of the heart, andincludes a central channel in the drive line and a guide wire; FIG. 19bshows an enlarged view of the motor, drive line, central channel, andguide wire.

DETAILED DESCRIPTION

FIG. 1 shows a schematic view of a first embodiment of a deviceaccording to the invention, said device being arranged in the leftventricular outflow tract of the heart. The schematic view shows a partof the heart 10 of a patient, wherein the device is arranged therein andanchored in the subcommissural triangles. The left ventricle 11, theright ventricle 12, the muscular septum 13 and the membranous septum 14are shown. The left atrium 15, the mitral valve 16 and the papillarymuscles 17 are also shown. Approximately in the middle of FIG. 1, theroot of the aorta 18 is schematically shown together with the aorticvalve leaflet 19. Due to the natural pumping activity of the heart,blood is pumped from the left ventricle 11 through the root of the aorta18 into the aorta, of which aorta ascendens 20 is shown. From there, theblood is further distributed into the different areas of the patient. Asschematically shown in FIG. 1, the embodiment of a device forcirculatory support of the heart 1 according to the invention isarranged in the left ventricle, more exactly in the left ventricularoutflow tract. The device 1 can be connected by means of an electricsupply line 2 with an exterior device such as a power supply or controlapparatus (not shown). FIG. 1 shows the exterior view of the holdingmeans 30 of the device 1, wherein in accordance with the presentembodiment, said holding means 30 comprises a cylindrical metal frame.The metal frame 30 is preferably realized as a so-called stent graft,which is configured in such a manner and made from such a material thatthe stent graft is collapsible, i.e. can be compressed to a relativelysmall diameter and can be implanted by means of a catheter device. Thestent graft can be expanded after implantation, for example by means ofa balloon catheter, or it is self-expandable on account of the structureand design of the stent graft. Nitinol is preferably used as thematerial for the metal frame or stent graft. FIG. 1 schematically showsthe metal frame as a mesh structure which, in accordance with thepresent example, comprises six wires which are substantially arranged ina circle and connected to a plurality of elongate wires arrangedperpendicularly thereto. The shown mesh structure is only exemplary andcan have different structures in which the wires are arranged indifferent manners for providing the desired collapsibility andexpandability. This metal frame is preferably produced as one piece.

As schematically shown in FIG. 1, the metal frame has a first end 31 anda second end 35.

The first end 31 of the metal frame is arranged adjacent to the root ofthe aorta 18 and has a shape that is adapted to the anatomy of the rootof the aorta 18. Preferably, this shape can be adapted individually tothe shape and size of the individual parts of the root of the aorta of apatient. In the present example, the edge of the second end 31 has threeconcave recesses, wherein only two of these recesses 32 a, 32 b areshown in this view. In the area of the recesses, the mesh frame 30 has ashorter length. Between two recesses, a respective projection 33 a, 33b, 33 c is formed. In the area of each projection, the metal frame has alength that is longer than the length in the area of the recesses. Thisdesign including the concave recesses and the projections lyingtherebetween makes sure that the metal frame follows the anatomic shapeof the area adjoining the root of the aorta. In this area adjoining theroot of the aorta, the metal frame is anchored.

In the example shown in FIG. 1, hooks 34 a, 34 b, 34 c are arranged ateach of the projections 33 a, 33 b, 33 c. There might be one respectivehook per projection or, as shown in FIG. 1, a group of hooks perprojection. In the shown example, a total of eight hooks are present,wherein four respective hooks are arranged along two parallel lines. Thehooks thus form a total of four pairs, wherein the hooks of each pairface each other. Also arrangements in which the hooks are offset arepossible, or a different number of hooks at each projection is possible.Furthermore, additional hooks can be provided in the area of the furtherportions of the first end 31. As schematically shown in FIG. 1 and asevident on the basis of the hooks 34 a and 34 c, the hooks are inclinedoutwardly and are directed towards the second end 35. As evident on thebasis of the hooks 34 b, these hooks can moreover be directed laterallyoutwardly, i.e. the free ends of the two hooks of each pair of hooksface away from each other. This design and this arrangement of the hooksat the outside of the metal frame 30 lead to an improved anchoring ofthe metal frame in the tissue of the left ventricular outflow tract ofthe heart.

In the present example, the second end 35 of the metal frame 30 has acircularly circumferential uniform edge. Further parts of the device forcirculatory support of the heart are arranged inside this metal frame 30or can be arranged therein after implantation of the holding means in anext step. These further parts are explained on the basis of thedescription of the following Figures.

FIG. 1 further schematically shows an electrical supply line 2, which isconnected to the holding means in the area of the septum 13 and guidedalong the interventricular septum. The part of the supply line showninside the left ventricle is referred to as intraventricular portion 2 aor intracardiac portion 2 a. As schematically shown in FIG. 1, the areaof the apex of the left ventricle 22 comprises a through opening 21through which the electrical supply line 2 is guided to the outside. Theportion of the electrical supply line lying outside the heart isreferred to as extracardiac portion 2 b.

This extracardiac portion 2 b of the electrical supply line can beguided directly to the outside of the skin surface of a patient or itcan end inside the body and preferably has a plug-in coupling at itsend, as will be described in the following. Alternatively, thiselectrical supply line can also be guided such that it is first guidedthrough the muscular septum 13 into the right ventricle 12 and is guidedvia a through opening at the diaphragmal side or at the front wall ofthe right ventricle 24 to the outside, or it can be guided eitherthrough the interatrial septum or the ventricular septum to the rightatrium and then transvenously via a large vein to the outside. The outerdiameter and the design of the supply line are such that they seal thethrough opening 21 in the apex of the left ventricle 22 and, ifapplicable, the through opening in the muscular septum 13 and thethrough opening of the right ventricle 24 (see FIG. 5).

FIG. 2 shows a schematic view of a second embodiment of the device forcirculatory support of the heart according to the invention, said devicebeing arranged in the left ventricular outflow tract inside the leftventricle of the heart. In view of the anatomy and the arrangement ofthe holding means in the subcommissural triangle and the design of theholding means, reference is made to the above description relating toFIG. 1. In detail, FIG. 2 shows a holding means 230 in the form of ametal frame or metal structure. The metal frame 230 has a first end 231,which is designed in a manner comparable to that of the first end 31 ofthe metal frame 30 of FIG. 1. It comprises recesses 232, projections 233and hooks 234. Reference is again made to the description of FIG. 1relating to the design of the first end.

The metal frame further comprises a second end 235. Spaced from thefirst end, preferably adjoining the recesses 232, at least a firstholding arm 251 is arranged, which extends diagonally and preferablyperpendicularly to the axial direction from one side of the metal frameto the other. At least one second holding arm 252, which is arranged inthe shown example parallel to the first holding arm 251, is arranged atthe first end 235 or adjacent to the first end 235 of the metal frame230. Alternatively, the second holding arm 252 can be arranged in aplane parallel to the plane in which the first holding arm extends,wherein the second holding arm is preferably arranged perpendicularly tothe direction of the first holding arm. Instead of providing one holdingarm, it is also possible to provide, e.g., two holding arms at the firstend and at the second end, said respective holding arms forming, e.g., across. It is also possible to provide more than two holding arms, forexample also an uneven number of holding arms. In the example shown inFIG. 2, only one holding arm 251 is provided at the first end, with afirst bearing 253 being arranged thereon. A second bearing 254 isprovided at the second holding arm 252. Both bearings are preferably inthe middle of the metal frame 230 and lie opposite one another along acentral axis of the metal frame 230. As schematically shown in FIG. 2,both bearings can have a respective concave bearing shell.

A rotor 240 is schematically shown inside the metal frame, said rotorhaving a rotational shaft 241 which is rotatably supported at one end inthe first bearing 253 and at the other end in the second bearing 254. Inthe example schematically shown in FIG. 2, the rotor 240 has twoopposite rotor blades 242, 243. When the rotor is driven, the bloodpresent in the left ventricle 11 is pumped in the direction of the rootof the aorta and flows through the aortic valve leaflet into the aorta.The rotor blades 242, 243 are realized in a suitable manner, inparticular they comprise a corresponding inclination of the rotorblades, so that the blood flows in the desired direction when the rotoris rotated around the rotational shaft 241.

In the example of FIG. 2, the rotor is driven by means of an electricmotor. In this shown example, the rotor comprises permanent magnets,wherein the first rotor blade 242 comprises a first permanent magnet244, which is referred to as magnetic south pole, and the second rotorblade 243 comprises a second permanent magnet 245, which is referred toas magnetic north pole. The permanent magnets can be formed integrallywith the rotor blades or as separate parts, for example, they can beprovided in the form of coatings at the free ends of the rotor blades.

The electric motor further comprises a stator which is arranged insidethe metal frame 230 and comprises electrical coils comprising wires. Thecoils can be present as separate parts or form an integral part of themetal frame 230. In FIG. 2, the coils are schematically indicated by thelines 260, which extend parallel to the axial direction from the firstend to the second end of the metal frame.

Like in a conventional electric motor, a magnetic field can be generatedby correspondingly activating the coils and supplying them with power,said magnetic field driving and rotating the rotor arranged inside. Therotational speed and the rotational power are adjusted by a suitablecoil arrangement and suitable voltages. The power supply of the electricmotor and the control of the rotational speed and the rotational powerare controlled via the electrical supply line 2 by means of a controlapparatus connected thereto. FIG. 2 only shows the intracardiac portion2 a of the electrical supply line and a part of the extracardiac portion2 b of the electrical supply line.

The second embodiment, which is schematically shown in FIG. 2, can beimplanted by means of a catheter in the left ventricular outlet tract ofthe heart, as will be explained in more detail below. To this end, themetal frame 230 is collapsible and subsequently re-expandable, asalready described in connection with FIG. 1, and also the common unit ofstator and rotor is collapsible and can be brought in the operatingposition. Thus, the entire device can be implanted at the same time as aunit or it can be implanted in several subsequent steps, wherein firstthe holding means 230 is implanted, and, if the stator is a separatepart, next the stator is implanted, and in a further step the rotor isimplanted. Alternatively, the stator and the rotor can also be implantedtogether. In an alternative embodiment in which the stator is anintegral component of the holding means, the rotor can be inserted afterthe holding means has been implanted.

FIG. 3 shows a schematic view of a third embodiment of the deviceaccording to the invention. This device comprises a metal frame 330which is comparable to the metal frame 30 of FIG. 1 and the metal frame230 of FIG. 2. The metal frame has a first end 331 with a plurality ofrecesses 332 and projections 333 arranged therebetween. Hooks 334 arearranged at the projections 333. The metal frame further has a secondend 335. The device is arranged in the left ventricular outflow tract ofthe heart in the same manner as described in connection with the devicesof FIG. 1 and FIG. 2. Reference is made to the respective description.

Different from the embodiment of FIG. 2, in the example shown in FIG. 3,two holding arms 351, 352 are arranged at the second end of the metalframe, said holding arms being directed radially inwardly and having anelectric motor 360 preferably releasably attached thereto. The electricmotor 360 has a rotational shaft 341, wherein two opposing rotor blades342 and 343 are arranged at the rotational shaft. At an end of theelectric motor 360 that is opposite the rotational shaft, the electricalsupply line is arranged. The electrical supply line 2, in the presentcase the intracardiac portion 2 a, can be connected to the electricmotor 360 by means of a plug or it can be firmly connected thereto.During operation of the electric motor, the rotor blades 342, 343arranged at the rotational shaft are rotated such that the blood in theleft ventricle is pumped in the direction of the root of the aortathrough the aortic valve leaflets into the aorta.

In the third embodiment shown in FIG. 3, the electric motor is arrangedin the area of the second end of the metal frame, and the rotationalshaft as well as the rotor blades face in the direction of the first end331 of the metal frame 330.

As will be explained in more detail below, the rotor blades arepreferably collapsible and can be implanted together with the electricmotor by means of a catheter. For this purpose, either the metal frame330 is first implanted and then the motor with the rotor blades arrangedthereon, or both parts are implanted together as a unit. The electricmotor is preferably closed and completely sealed. As schematicallyshown, it has a cylindrical shape in which the units such as stator androtor are integrated. The motor can have different configurations whichare known in connection with electric motors. It can be configured as abrushless DC motor with electronic converter, as an EC motor or as apermanently excited synchronous motor or as an AC motor. The holdingarms 351, 352 are preferably realized as metal supports. The latter canbe made in one piece with the metal frame. This accordingly also appliesto the structure of the first and second holding arms of the device ofFIG. 2.

The rotational speed and rotational power can be adjusted on the basisof the voltage and the respective design of the electric motor. Thepumping power can be adjusted in accordance with the rotational power ofthe electric motor and the design of the rotor blades.

FIG. 4 shows a schematic view of a fourth embodiment of the deviceaccording to the invention. This embodiment is comparable to the thirdembodiment of FIG. 3. Therefore, in the following only the differenceswill be discussed. As to the rest, reference is made to the descriptionof FIG. 3, FIG. 2 and FIG. 1. When comparing FIGS. 3 and 4, it isevident that the insertion direction of the electric motor 460 insidethe metal frame 340 is different. The metal frame 430 is arranged in thesame manner as described in connection with the holding means of FIGS.1, 2 and 3 in the left ventricular outflow tract of the heart. Inparticular, hooks 434 are provided at the projections 433 at the firstend 431 of the metal frame. In the embodiment shown in FIG. 4, twoholding arms 451, 452 are schematically arranged in a manner opposingeach other in the area of the first end of the metal frame. Theseholding arms are directed radially inwardly and, as schematically shown,they are arranged at an angle with respect to a plane in the directiontowards the second end 435 of the metal frame 430. The electric motor460 is attached, or releasably attached, to the ends of the holding arms451, 452.

The electric motor 460 has a rotational shaft 441 at which two opposingrotor blades 442, 443 are arranged. The rotor blades are in the planeadjacent to the second end 435 of the metal frame 430 or directly in theplane in which the second end 435 lies. In the embodiment shown in FIG.4, the electrical supply line 2 is connected at the side of the electricmotor 460, exemplarily at the first end of the electric motor 460. Here,the electrical supply line is guided through an opening in the metalframe or around the metal frame 430 to the outside of the metal frame inthe area of the muscular septum 13 and further in the direction of theapex of the left ventricle. The intracardiac portion 2 a and a part ofthe extracardiac portion 2 b of the electrical supply line are shownhere. With respect to the further description of the electric motor aswell as the further structure of the device, reference is made to thedescription of FIG. 3.

FIG. 5 shows a fifth embodiment of the invention, in which the metalframe 530 is shown in the left ventricular outflow tract of the heart.The metal frame 530 comprises the same parts as the metal framesdescribed in connection with FIG. 1, 2, 3 or 4. The hooks 534 areexemplarily shown here. As in particular comparable with the firstembodiment of FIG. 1, an electrical supply line 52 is arranged at thesecond end of the metal frame 530. Like in FIG. 1, the device isarranged in the area of the muscular septum 13. In contrast to theembodiment of FIG. 1, the supply line 52 a does not lead directly to theapex of the left ventricle but through a through opening 525 in themuscular septum 13 further into the right ventricle 12 and through athrough opening 526 in the wall of the right ventricle in the vicinityof the apex 24 of the heart. The electrical supply line thus has a leftventricular portion 52 a or intracardiac portion 52 a, a transseptalportion 52 b leading through the through opening 525 in the muscularseptum 13, a right ventricular portion 52 c and an extracardiac portion52 d, of which only a part is visible.

This embodiment of the invention is advantageous in that a sealing ofthe through opening 526 in the apex 24 of the right ventricle can beachieved safely by means of the electrical supply line extending throughit. The pressure in the right ventricle is generally lower than thepressure in the left ventricle. This leads to a more easily achievablesealing at the through opening 526.

In the fifth embodiment shown in FIG. 5, the pump arrangements shown inFIG. 2, FIG. 3 and FIG. 4 can be used. Therefore, reference is made tothe respective descriptions. In view of the holding means, reference ismoreover made to the description relating to FIG. 1.

FIG. 6 shows a schematic view of a sixth embodiment of the deviceaccording to the invention. This embodiment largely corresponds to thefifth embodiment, so that reference is made to the above description ofFIG. 5 in connection with FIGS. 1 to 4. The device comprises a metalframe 530, which is comparable to the metal frame 530 and thecorresponding metal frames of FIGS. 1 to 4, wherein, for example, thehooks 534 are shown. In contrast to the embodiment of FIG. 5, theelectrical supply line 62 is divided into a left ventricular portion 62a, a septal portion 62 b and an extracardiac portion 62 c. Theelectrical supply line 62 is connected to the second end of the metalframe 530 and leads directly adjacent to the first end of the metalframe into the muscular septum 13. The supply line is further guidedthrough the muscular septum 13 and exits at the apex. In other words,there is provided a through opening 527 which extends through themuscular septum 13 in the longitudinal direction from the side of theleft ventricle 11 to the outside of the heart.

The relatively long way of the electrical supply line through theelongate through opening 527 in the muscular septum 13 leads to animproved sealing against the pressure prevailing in the left ventricle11.

The pump arrangements shown in FIG. 2, FIG. 3 and FIG. 4 can be used inthe sixth embodiment shown in FIG. 6. Therefore, reference is made tothe respective description. In view of the holding means, reference ismoreover made to the description in connection with FIG. 1.

FIG. 7 shows a seventh embodiment of the invention, wherein the metalframe 530 is shown in the left ventricular outflow tract of the heart.The metal frame 530 comprises the same parts as the metal framesdescribed in connection with FIGS. 1 to 5. The hooks 534 are exemplarilyshown. As in particular comparable with the first embodiment of FIG. 1,an electrical supply line 2 is arranged at the second end of the metalframe 530. Like in FIG. 1, the device is arranged in the area of themuscular septum 13. In contrast to the embodiment of FIG. 1, the supplyline 2 a does not lead directly to the apex of the left ventricle butthrough a through opening 528 in the muscular septum 13 further into theright ventricle 12 and from there through the tricuspid valve 6 into theright atrium 7 b, and it is then guided through a vena cava 8 to a largeperipheral vein and from there through a through opening into thesubcutaneous tissue (not shown). The electrical supply line thus has aleft ventricular portion 72 a, a transseptal portion 72 b extendingthrough the through opening 528 in the muscular septum 13, a rightventricular portion 72 c and a right atrial portion 72 d and a cavalportion 72 e, of which only a part is visible.

This embodiment of the invention is advantageous in that a sealing ofthe through opening in a large vein (e.g. subclavian vein, jugular vein,axillary vein, or femoral vein) can be achieved safely by means of theelectrical supply line extending through it. A through opening of thiskind is nowadays often used for implanting cardiac pacemakers, whichgenerally does not lead to any problems. The venous pressure isgenerally much lower than the pressure in the heart. This leads to amore easily achievable sealing at the through opening from the vein intothe subcutaneous tissue.

FIG. 8 shows an eight embodiment of the invention, in which the metalframe 530 is shown in the left ventricular outflow tract of the heart.The metal frame 530 comprises the same parts as the metal framesdescribed in connection with FIG. 1, 2, 3 or 4. The hooks 534 areexemplarily shown here. As in particular comparable with the firstembodiment of FIG. 1, an electrical supply line is arranged at thesecond end of the metal frame 530. Like in FIG. 1, the device isarranged in the area of the muscular septum 13. In contrast to theembodiment of FIG. 1, the supply line does not directly lead to the apexof the left ventricle but through the mitral valve 16 into the leftatrium 7 a, then further through the interatrial septum 7 c into theright atrium 7 b, and it is then guided through a vena cava 8 to a largeperipheral vein and from there through a through opening into thesubcutaneous tissue (not shown). The electrical supply line thus has aleft ventricular portion 82 a, a left atrial portion 82 b, a transseptalportion 82 c leading through the through opening 529 in the interatrialseptum 7 c, a right atrial portion 82 d and a caval portion 82 e, ofwhich only a part is visible.

The access through the atrial septum is nowadays often usedpercutaneously for diagnosing and treating cardiac arrhythmia in acatheter laboratory. This embodiment of the invention is advantageous inthat a sealing of the through opening in a large vein can be safelyachieved by means of the electrical supply line extending through it. Athrough opening of this kind is nowadays often used for implantingcardiac pacemakers, which, as a rule, does not lead to any problems. Thevenous pressure is generally much lower than the pressure in the heart.This leads to a more easily achievable sealing at the through openingfrom the vein into the subcutaneous tissue.

FIG. 9 schematically shows a first embodiment of a system according tothe invention for handling the device of FIGS. 1 to 6 of the invention.First of all, the anatomy is explained. FIG. 9 schematically shows apart of the heart 10, namely the left ventricle 11 and the rightventricle 12. Said part of the heart is followed by the aorta, and theascending aorta 18, the aortic arch 21, the descending aorta 22 and thethoracoabdominal aorta 23 are following. The latter is further connectedto the common iliac artery 24 a and the external iliac artery 24 b andfurther with the common femoral artery 25 in the groin 26. The diaphragm27 is also schematically shown.

The embodiment of a system for handling the device for circulatorysupport of the heart according to the invention as shown in FIG. 9serves for an endovascular implantation of the device. The embodimentfor handling the device according to the invention comprises anendovascular wire 91 having two ends 91 a and 91 b and being insertedthrough a puncture site in the heart or in a large vein into the vesselsystem. In the area of the apex of the heart 10, an arterial lock 92 isinserted into the left ventricle, either via the apex of the heart orvia a right ventricular transseptal access, a septal access, by directlypuncturing the heart, or by puncturing a large vein and subsequentlypuncturing the atrial septum or the ventricular septum. One end 91 b ofthe wire is guided outwardly via the aorta 18, 21, 22, 23 and the iliacartery 24 to the femoral artery 25. It is thus possible to pullsimultaneously at both ends of the wire (“tooth-floss method”), whereina precise control of the guide wire and thus the heart support system ispossible during insertion and releasing.

FIG. 9 further shows an arterial sheath 93 in the femoral artery.

Once the wire has been inserted, the device is inserted into the vesselsystem through the femoral access in the area of the groin and moved viathe endovascular wire to the heart and is then released in the leftventricular outflow tract of the heart and anchored in thesubcommissural triangles. It will be shown below in connection with FIG.17 that a precise repositioning of the anchoring means can be achievedby pulling at both ends of the guide wires, leading to a decrease in thediameter.

The electrical supply line connected to the device is pulled out bymeans of an endovascular wire through the puncture site in the heartafter the device has been anchored in the left ventricular outflowtract. After releasing the device, the endovascular wire serves forpulling the electrical supply line out of the left ventricle of theheart, and the supply line is pulled out through the access way(possibly left ventricle, septum, right ventricle, large vein aftertransseptal or transatrioseptal puncturing). The electrical supply linehas a larger diameter than the wire, so that the through opening in theheart is sealed by means of the electrical supply line.

The endovascular wire is finally pulled completely out of the body andthereby pulls the electrical supply line also to the intended site atthe surface of the body of the patient. As already mentioned, theelectrical supply line can have an electrical coupling at its free end,wherein said electrical coupling can either be connected directly to anapparatus for supplying voltage and for controlling the device or it canbe connected to a plug-in connection from which the electrical supplyline is guided further outwardly to an apparatus for supplying voltageand for controlling the device.

FIGS. 10a to 10e show various views of details of a ninth embodiment ofa device according to the invention. This ninth embodiment can beimplanted in the left ventricular outflow tract inside the leftventricle of a heart, as described, e.g., on the basis of FIG. 1. FIG.10a shows a side view of the device according to the invention, whichcomprises a holding means in the form of a metal frame 730. Inparticular from the top views of FIGS. 10b and 8c it is evident that themetal frame 730 has a cylindrical shape. As suggested in FIG. 10a , thecylindrical shape can have a barrel shape in which the outer surface isbulged outwardly. The holding means further comprises a first end 731,which forms an anatomically shaped subvalvular part of the metal framewhich is anchored in the subcommissural triangles in the leftventricular outflow tract. As already described above in connection withFIGS. 1 to 6, three recesses 732 being adapted to the anatomic shape areformed at the first end 731. Respective projections 733 having one hookor a plurality of hooks 734 at their outer sides are present between therecesses.

FIG. 10a schematically shows a first holding arm 751, which extendsperpendicularly relative to the image plane. This first holding arm 751is fixed to the metal frame 730 in the area of the first end 731. FIG.10a further schematically shows a second holding arm 752 at the secondend 735 of the metal frame 730. This holding arm 752 extends in theplane of the drawing, i.e. substantially perpendicularly with respect tothe first holding arm 751. In particular from the detailed view of FIG.10d it is evident that the first holding arm 751 has a first bearing 753which is cup shaped, i.e. has a concave bearing shell. The secondholding arm 752 has a second bearing 754 which, in the present example,is knob-shaped, i.e. has a bearing projection. It is also schematicallyshown in FIG. 10d that the rotor 740 has a rotational shaft 741 which isconvex at the first end and concave at the second end, wherein thedesign, in particular the shape and size, is adapted to thecorresponding bearing shell 753 and/or the bearing knob 754. Twoopposing rotor blades 742, 743 are arranged at the rotational shaft 741.As evident from the schematic top view of FIG. 10b , the rotor bladeseach have an asymmetric shape. The rotor blade 742 is essentiallytriangular with a convex front side 742 a, a concave rear side 742 b anda circular free end 742 c. The second rotor blade 743 is arrangedapproximately 180° offset thereto, said second rotor blade also having aconvex front side 743 a, a concave rear side 743 b and a circular freeend 743 c. With reference to FIG. 10d it is pointed out that the rotorblades can have a selectable angle of attack in the axial direction, sothat the pumping power is adjusted accordingly when the rotor isrotating.

In the top view of FIG. 10c the rotor has been omitted. The firstholding arm 751 at the first end and the second holding arm 752 at thesecond end of the metal frame 730 are shown. As evident from acombination of FIGS. 10a and 10c , the electrical supply line 2 isarranged or connected in the area of the second end 735 adjacent to anend of the second holding arm 752.

FIG. 10e schematically shows the stator with a plurality of electricalcoils, wherein in this example the coils are arranged in pairs oppositeto one another. In the clockwise direction, electrical coils 761 and 762are shown in a manner opposite to one another. The next pair is offsetby 90° relative to the rotational direction and is formed by coils 763and 764. Between this first and second pairs of coils, coils 765 and 766are shown in a manner opposite to one another and form a third pair ofcoils. Starting from this third pair of coils, coils 767 and 768 arearranged in a manner offset by 90° and opposite to one another and forma fourth pair of coils. In the middle of the stator 760, the rotationalshaft 741 is schematically shown.

As comparable with the embodiment described on the basis of FIG. 2, theninth embodiment comprises rotor blades having permanent magnets 744 and745 formed at their respective ends. By accordingly activating the pairsof coils and correspondingly supplying them with power, a magnetic fieldis generated, which drives and accordingly rotates the rotor. In thepresent example, each of the four pairs of coils has an opposite windingdirection, so that in case current flows through an individual pair ofcoils, opposite electromagnetic fields are generated. An own current isflowing through each pair of coils, wherein said current flow istemporally offset relative to the next pair of coils and possibly has asine wave and leads to a rotational acceleration of the rotor with itsblades in the desired direction. In case of a temporally offset currentflow through the stator coils, magnetically opposite magnetic polesnorth and south are generated, which move in a circle with the frequencyof the temporally offset sine-shaped current flows. These magnetic polesattract the corresponding opposite magnetic poles generated by thepermanent magnets at the rotor blades, so that the rotor is rotated. Byaccordingly switching the magnetic field further, the rotor can berotated.

The motor can have different electric motor designs. The motor can be,e.g., a brushless DC motor with electronic converter, i.e. a so-calledBLDC motor, also known as electronically commutating DC motor. In BLDCmotors, the rotor is normally realized by means of a permanent magnet,the stationary stator comprises the coils, which are activated in atemporally offset manner by an electronic circuit, so that a rotationalfield is generated, causing a rotational moment at the permanentlyexcited rotor. Preferably it is a stepper motor, i.e. the commutation ofthe BLDC motor is realized independent of the position, rotational speedand moment loading of the rotor. By means of the magnetic field of thestator, the permanently magnetic rotor of the stepped motor is alignedsuch that a rotational movement is generated. The motor can also berealized as a permanently excited synchronous motor or as an AC motor.

FIGS. 11a, 11b and 11c show schematic views of a first embodiment of arotor with foldable rotor blades. This rotor can be used, e.g., in thesecond embodiment of FIG. 2 or in the ninth embodiment of FIG. 10,wherein the rotor is inserted by means of a catheter 910 after the metalframe with the stator therein has been anchored in the left ventricularoutflow tract. The rotor 940 has a rotor shaft 941 at which rotor blades942, 943 are arranged in such a manner that the rotor blades arefoldable. FIG. 11a schematically shows the rotor with foldable rotorblades inside a tubular flexible insertion instrument of a catheter. Therotor blades 942 and 943 are folded substantially along the rotationalshaft 941. FIG. 11b shows the rotor blades in the semi-unfolded state,after they have been released from the catheter. FIG. 11c shows therotor with completely unfolded rotor blades. In this first embodiment ofthe rotor, the rotor blades are folded diametrically, i.e. the firstrotor blade 942 faces towards a first end of the rotational shaft 941and the second rotor blade 943 faces towards a second end of therotational shaft 941.

FIGS. 12a, 12b and 12c schematically show a second embodiment of a rotorwith foldable rotor blades. The rotor 1040 has a rotational shaft 1041at which two rotor blades 1042, 1043 are arranged opposite one another.In FIG. 12a the rotor is schematically shown with folded blades, whereinboth rotor blades are folded with their free ends in the same directionand end at an end of the rotational shaft 1041 of the rotor 1040. Insidethe catheter 1010 or the flexible insertion instrument, the rotor bladesare completely folded. FIG. 12b shows the rotor with semi-unfolded rotorblades. In FIG. 12c the rotor blades are completely unfolded.

In both embodiments of FIGS. 11 and 12, the rotor blades are arranged atthe rotational shaft of the rotor preferably by means of a hinge orjoint. Alternatively, the rotor blades can be collapsible andunfoldable. Thus, the rotor blades can be folded and unfolded again.Preferably, unfolding of the rotor blades occurs automatically as aconsequence of a restoring force caused in the hinge or joint and/or inthe rotor blades. Alternatively, the rotor blades can be unfolded bymeans of the catheter instrument.

FIGS. 13a and 13b show schematic developed views for anatomicallydescribing the left ventricular outflow tract and the site where thedevice according to the invention is arranged. The device according tothe invention has been omitted and the dotted line shows the anatomicsite where the metal frame or stent graft is anchored. For example, thedevice can be implanted by means of the system for handling the devicedescribed with reference to FIG. 9. FIG. 13a schematically shows theanatomy with the aorta ascendens 120, the sinotubular junction 121 andthe aortic valve annulus 190. Furthermore, the ventriculo-arterialjunction 131 and the ventricular myocardium 130 are schematically shown.In this area, the subcommissural triangles 142 are schematically shown.Thus, the arterial wall on the ventricular side of the aortic valve isshown. (Synonyms of the anatomical structures in German: subkommisuralesDreieck=subcommissural triangle, ventrikulärer Anteil derAortenwand=ventricular portion of the aortic wall.)

FIG. 13b shows further details of the anatomy, wherein in the area ofthe aorta ascendens 120, the right coronary ostium 122 and the leftcoronary ostium 123 are shown. Furthermore, the membranous part of theinterventricular septum 141 is schematically shown below thesubcommissural triangles. Directed further below from there, the mitralvalve is schematically shown, i.e. the front leaflet of the mitral valve161. As already discussed, the dotted lines in FIGS. 13a and 13b are thesites where the device according to the invention is anchored.

FIG. 13c shows a schematic view of the aortic root anatomy. Morespecifically FIG. 13c shows the sinotubular junction 133, theaortoventricular junction 134 and the basal ring 135. The attachmentedges 136 of the aortic valve leaflets are shown as semicircular curvesextending from the sinotubular junction 133 in the direction of thebasal ring 135. The subcommissural triangles 137 are the part of thefibrous aortic wall on the ventricular side of the aortic valve abovethe basal ring 135 and above the aortoventricular junction 134.

Anchoring of the holding means is performed in the fibrous tissue abovethe basal ring 135 and above the aortoventricular junction 134 but belowthe aortic valve leaflets. Preferably, the holding means is anchored inthe three small triangular zones between two neighboring attachmentedges 136 of the aortic valve leaflets.

FIG. 14 shows a schematic view of a cross-section through the membranousseptum for anatomically describing the front part of the leftventricular outflow tract and for explaining the site where the deviceaccording to the invention is arranged. The dotted line again shows theanatomic site where the metal frame/stent graft is anchored. Equalparts, which are visible in FIG. 13, are marked here with the samereference numbers. Thus, reference is made to the above description ofFIG. 13. In particular the portion of the \ membranous interventricularseptum 141 having an atrial portion 141 a and a ventricular portion 141b is schematically shown. This cross-section additionally schematicallyshows the bundle of His 141 c, which guarantees the atrioventricularconduction of the heart. It is schematically shown that the tricuspidvalve leaflet 162 is arranged at the interventricular septum on theright side of the heart, which is opposite the side at which the deviceaccording to the invention is anchored.

FIG. 15a is a schematic view of the device for circulatory support ofthe heart according to the invention, which is implanted in the leftventricle, as well as of the supply lines connected thereto and thecontrol apparatus lying outside the body of a patient. In the shownexample, the device 1 for circulatory support of the heart is implantedin the heart 10. The electrical supply line is guided through the apexof the left ventricle towards the outside of the heart. The extracardiacportion of the electrical supply line 2 b is schematically shown. Theextracardiac portion of the control line 2 b ends at an electricalconnector 3. This connector 3 is preferably arranged in the subcutaneoustissue of the abdomen. The connector serves for connecting a secondelectrical supply line 2 c and 2 d, which leads to a control apparatus5. If the portion of the supply line lying outside the body is damagedor in case of an infection or in case the supply line does not correctlyheal into the skin outlet site 4, this portion of the supply line can bereplaced and separated from the implanted portion of the supply line bymeans of the connector, and a new portion of the supply line can beconnected to the implanted part or the new portion of the supply linecan be arranged at another skin outlet site. This is advantageousbecause it is not necessary to explant and replace the entire system andan infection of the entire system can be avoided. The control apparatus5 lies outside the body of the patient. The control apparatus 5 servesfor providing the supply voltage for the electrical device as well asfor supplying the corresponding control signals. Furthermore, sensorsignals can be transmitted via the electrical supply line from theelectrical device to the control apparatus 5. The control apparatus ispreferably battery-driven, wherein the contained batteries are eitherchargeable or replaceable. The second electronic supply line can bedivided into a first portion 2 c, which is guided in the subcutaneoustissue, and a second portion 2 d, i.e. the extracorporal portion of theelectrical supply line. The electrical supply line exits the body at anexit site 4 which, in the present case, lies approximately in the areaof the right front abdomen.

FIG. 15b is a schematic view of the same embodiment as that of FIG. 15a, wherein the parts lying in the body of the patient are not visible.

FIG. 16a is an enlarged schematic view of a first embodiment of aconnector 3, which is schematically shown in FIG. 15a , wherein thisconnector is realized as a plug-in connector. In FIG. 16a , the plug-inconnector is schematically shown, wherein the plug and the coupling areseparate from each other. In FIG. 16b , the plug is connected to thecoupling. In the shown example, the plug-in connector has a coupling 60and a plug 70. The coupling 60 is arranged at the end of theextracardiac portion 2 b of the electrical supply line. The plug 70 isarranged at the end of the intracorporal portion 2 c of the electricalsupply line. A cable 61 a with a plurality of leads 61 b is arrangedinside the electrical supply line. Each individual lead 61 b isconnected to a corresponding connection sleeve 63 of the coupling 60. Inthe shown example, a total of nine connection sleeves are arranged on acircle in the coupling. The connection sleeves end at a distance fromthe end of the coupling 60. On the other side, the plug 70 is shown. Acable 7 a with a plurality of leads 71 b is arranged inside the supplyline 2 c. Each lead is electrically connected to a corresponding pin 73of the plug. The pins project from the end of the plug 70. The length ofthe pins is adapted to the length of the connection sleeves. In a firstportion 74, the plug has a reduced diameter. In front of a steppedprojection 75 on a second portion 76 with larger diameter, the plug hasa sealing ring 75 a. As schematically shown in FIG. 16b , the plug isinserted into the provided cylindrical recess in the coupling so farthat, on the one hand, the pins 73 are inserted into the correspondingconnection sleeves 63 and, on the other hand, a face 65 of the coupling60 adjoins the stepped projection 75 of the plug. As schematicallyshown, the sealing ring 75 a is inside the recess in the coupling 60.Thus, a water-proof and reliable electrical connection between the twoends of the electrical supply line is achieved.

FIGS. 17a and 17b show an enlarged schematic view of a furtherembodiment for handling and in particular for repositioning/adjustingthe device according to the invention. As schematically shown in FIG.17a , a metal frame 30 has a first relatively large diameter. Forhandling and for repositioning the metal frame, the metal frame isbrought to a smaller diameter. For example, the metal frame can bereduced to the diameter shown in FIG. 17b . In this example, thediameter is reduced by applying a tension force to both ends of themetal frame. In this example, three wires 177 a, b and c catch hold ofthe first end of the metal frame, wherein these wires can be attached tothe projections in the area of the first end. These wires are guided inthe aorta ascendens via a first catheter 173 and via a long lock to thearteria femoralis, so that it is possible to pull said wires fromoutside. In this example, also three wires 176 a, b and c can beattached to the second end of the metal frame 30, said wires beingguided via a second catheter 172 through an arterial lock (not shown) inthe apex of the heart, in the right ventricle or in a large vein to theoutside of the body. If, on the one hand, the wires 177 a, b, c arepulled in the direction of the arrow A and, on the other hand, the wires176 a, b, c are pulled in the direction of the arrow B, the shape of themetal frame can be changed such that a smaller diameter is present andthus at the same time the anchoring of the device in the leftventricular outflow tract is released. In this manner, the metal frameis brought to a partially collapsed state. If the metal frame or stentgraft is self-expandable, the metal frame returns into the fullyexpanded state when the tensile forces are decreasing.

The ends of the endovascular wires 176 a, b, c are realized as eyes orwire loops and can be attached to accordingly shaped hooks (not shown)in the area of the second end of the metal frame. Likewise, theendovascular wires 177 a, b, c can have eyes or can be realized as wireloops, which can be connected to corresponding hooks (not shown) at thefirst end of the metal frame. After repositioning or after handling ofthe device, the wires can be released from the first and/or second endand pulled out to the outside.

This device is advantageous in that an implanted device can be newlypositioned, because the landing zone for the anchorage is relativelynarrowly defined in terms of anatomy (see FIGS. 13 and 14), or, ifnecessary, can be removed completely from the heart.

In the above embodiments the device for supporting the heart has beendescribed with reference to an implantation in the left ventricularoutflow tract. However, it is explicitly pointed out that the device canalso be arranged in the right ventricular outflow tract, so that thedescription similarly applies.

FIG. 18 shows a schematic view wherein a device according to theinvention is arranged in the right ventricular outflow tract of theheart. Any device according to one of the above described embodimentscan be used in the right ventricular outflow tract.

The schematic view of FIG. 18 shows a part of the heart 10 of a patientcomprising the left ventricle 1811, the right ventricle 1812, themuscular portion of the interventricular septum 1813 and the membranousportion of the interventricular septum 1814. The pulmonary artery 1803,the pulmonary valve 1804, right pulmonary artery 1805, the leftpulmonary artery 1806 are also shown. FIG. 18 further shows thetricuspid valve 1815, the right atrium 1817, the inferior vena cava 1820and the superior vena cava 1821 as well as the ascending aorta 1818 andthe mitral valve 1816. Approximately in the middle of FIG. 18, the rootof the pulmonary artery 1803 is schematically shown together with thepulmonary valve 1804. The device 1801 is arranged in the outflow tractof the right ventricle 1812 and anchored in the sub-commissuraltriangles below the pulmonary valve 1804. Due to the natural pumpingactivity of the heart, blood is pumped from the right ventricle 1812through the root of the pulmonary artery 1803 into the pulmonary artery.From there, the blood is further distributed into the different areas ofthe lung. The device 1801 can be connected by means of an electricsupply line 1802 with an exterior device such as a power supply orcontrol apparatus (not shown). In this example the electric supply line1802 extends through the superior vena cava 1821.

FIG. 18 shows the exterior view of the holding means 1830 of the device1801, wherein in accordance with the present embodiment, said holdingmeans 1830 comprises a cylindrical metal frame. The first end 1831 ofthe metal frame 1830 is arranged adjacent to the root of the pulmonaryartery 1803 and has a shape that is adapted to the anatomy of the root.Preferably, this shape can be adapted individually to the shape and sizeof the individual parts of the root of the pulmonary artery of apatient. In the present example, the edge of the first end 1831 hasthree concave recesses, wherein only two of these recesses 1832 a, 1832b are shown in this view. In the area of the recesses, the mesh frame1830 has a shorter length. Between two recesses, a respective projection1833 a, 1833 b, 1833 c is formed. At each projection several hooks 1834are provided. As regards the further features reference is made to theabove description of the embodiments with reference to the deviceimplanted in the left ventricle.

FIG. 19 shows a schematic view of another embodiment of the invention.As regards the anatomy and the arrangement of the holding meansreference is made to the above description in particular with referenceto FIGS. 1 to 4. In this embodiment a small rotary blood pump 1960, forexample an axial flow pump or a centrifugal pump, is arranged in thesame position as in FIGS. 1 to 4 in the sub-valvular position of theleft ventricular outflow tract adjacent to the aortic valve 1919. Theholding means is a stent or a stented graft 1930 comprising severalhooks 1934 at each respective projection 1933 of the stent 1930. In thisembodiment the stent 1930 comprises two radial holding arms 1951 and1952 being attached at a first end of the stent and extending in aninclined manner to the second end of the stent. There can be one, two,three or more holding arms. The pump 1960 is secured in place andattached to the stent 1930 by the holding arms 1951 and 1952 in asimilar manner as the pump in FIGS. 3 and 4. Reference numeral 1941depicts the central rotor or impeller, which can be held in place byconventional pencil tip bearings or by magnetically levitated bearings.The rotary pump 1960 is connected with a driveline. In FIG. 19 theintraventricular portion 2 a and a part of the extracardiac portion 2 bof the driveline is shown. This rotary blood pump 1960 aspirates theblood from the left ventricular cavity and ejects the blood across theaortic valve into the systemic arterial circulation. Alternatively oradditionally a similar small rotary blood pump can also be attached to astent holding the pump in the right ventricular outflow tract.

Although the invention has been illustrated and described in detail onthe basis of the Figures and the corresponding description, thisillustration and this detailed description should be understood as beingillustrative and exemplarily and not as limiting the invention. It is amatter of fact that experts can make changes and modifications withoutleaving the scope and gist of the following claims. In particular, theinvention also comprises embodiments with any combination of featureswhich are mentioned or shown above or below in connection with differentembodiments.

The invention also comprises individual features in the Figures, even ifthey are shown therein in connection with other features and/or have notbeen mentioned above or below. Moreover, the alternatives of embodimentsdescribed in the Figures and in the description and individualalternatives and the features thereof might be excluded from thesubject-matter of the invention and/or from the disclosedsubject-matter. The disclosure comprises embodiments which compriseexclusively the features described in the claims and/or in theembodiments and also embodiments which additionally comprise otherfeatures.

I claim:
 1. A circulatory support device for an in-vivo heart, saidin-vivo heart including an aortic valve and a pulmonary valve,comprising: a pump-holder configured to be disposed in an outflow tractof the heart, wherein the pump-holder comprises an anchor configured tobe placed in subcommissural triangles underneath the aortic valve or thepulmonary valve, in a blood flow direction on a ventricular side of theaortic valve and the pulmonary valve, respectively, a pump configured tobe placed in the pump-holder, wherein the pump is one of: (a) disposablein the pump-holder after the pump-holder has been placed in thesubcommissural triangles underneath the aortic valve and the pulmonaryvalve, and (b) connected to the anchor, and wherein the circulatorysupport device does not extend through the aortic valve or the pulmonaryvalve.
 2. The circulatory support device of claim 1, wherein thepump-holder comprises at least one expandable stent, wherein theexpandable stent is at least one of configured to be expanded by anapplied force and is a self-expanding stent.
 3. The circulatory supportdevice of claim 2, wherein the pump comprises an electric motorincluding a stator assembly coupled to the stent and a rotor assemblycentrally disposed in the stator assembly.
 4. The circulatory supportdevice of claim 3, wherein the stator assembly and the rotor assembly ofthe electric motor comprise electrical coils and/or permanent magnets.5. The circulatory support device of claim 2, wherein the at least oneexpandable stent includes a flexible, collapsible suspension disposed inthe stent.
 6. The circulatory support device of claim 2, wherein theapplied force is supplied by a balloon.
 7. The circulatory supportdevice of claim 1, wherein the pump comprises a rotational shaftincluding at least one collapsible blade, and during operation of thepump blood is pumped in a direction of the aortic valve or the pulmonaryvalve, respectively.
 8. The circulatory support device of claim 1,wherein the pump is one of a rotary blood pump, an axial flow pump witha central impeller, and a centrifugal flow pump, the pump-holderincludes a stent graft including a holding arm, and the pump is attachedto the stent graft via the holding arm such that the pump is secured ina left or right ventricular outflow tract underneath the aortic orpulmonary valve.
 9. The circulatory support device of claim 3, whereinthe electric motor includes an electrical supply line that isconnectable to a power supply and configured such that the electricalsupply line is disposable in the heart via a percutaneously placed guidewire, and the electrical supply line provides a seal of an opening inthe heart for the percutaneously placed guide wire.
 10. The circulatorysupport device of claim 9, wherein the electrical supply line ischaracterized by a length, a width, and a flexibility and is configuredto be guided from a left and/or right ventricle of the heart through anapex of the left and/or right ventricle of the heart to a site at a skinsurface of a patient.
 11. The circulatory support device of claim 9,wherein the electrical supply line is characterized by a length, awidth, and a flexibility and is configured to be guided from a leftand/or right ventricle of the heart through a lateral wall of the leftand/or right ventricle or through a lower wall of the left and/or rightventricle and to a site at a skin surface of a patient.
 12. Thecirculatory support device of claim 9, wherein the electrical supplyline is characterized by a length, a width, and a flexibility and isconfigured to extend in a cardiac septum and to be guided to a site at askin surface of a patient.
 13. The circulatory support device of claim9, wherein the electrical supply line is characterized by a length, awidth, and a flexibility and is configured to be guided from a leftventricle of the heart through a cardiac septum into a right ventricleand then further through a free wall of the right ventricle and to asite at a skin surface of a patient.
 14. The circulatory support deviceof claim 9, wherein the electrical supply line is characterized by alength, a width, and a flexibility and is configured to be guided from aleft ventricle of the heart through a cardiac septum into a rightventricle, and through a tricuspid valve into a right atrium, thenthrough a vena cava to a large peripheral vein and through athrough-opening into subcutaneous tissue and to a site at a skin surfaceof a patient.
 15. The circulatory support device of claim 9, wherein theelectrical supply line is characterized by a length, a width, and aflexibility and is configured to be guided from a left ventricle of theheart through a mitral valve into a left atrium, then through aninteratrial septum into a right atrium, then through a vena cava to alarge peripheral vein and through a through-opening into subcutaneoustissue and to a site at a skin surface of a patient.
 16. A systemcomprising a catheter configured to enable at least one of implantationof the circulatory support device of claim 1 and to allow positioningand adjusting of the implanted circulatory support device in a leftand/or right ventricle of the heart of a patient.
 17. The systemaccording to claim 16, wherein the catheter includes a guide wireconfigured to be used for pulling an implanted electrical supply lineout of the heart either directly or through a venous system thereof. 18.The circulatory support device of claim 9 further comprising a plug-inconnector for the electrical supply line configured to be disposed insubcutaneous tissue of a patient and to provide an electrical connectionbetween an implanted part of the electrical supply line and anoutwardly-guided part of the electrical supply line.
 19. A fixing devicefor a circulatory support device of claim 1, comprising an expandablestent for an intracardiac heart support system, wherein said stent isconfigured to be partially collapsed after having initially beeninserted by pulling endovascular wires in opposite directions and to bere-expanded after the circulatory support device has been repositionedand/or adjusted in a left and/or right ventricular outflow tract.
 20. Aminimally invasive method to implant a left or right ventricularcirculatory support device of claim 1 in a sub-valvular position of anoutlet valve of the respective ventricle, comprising: inserting thecirculatory support device through a large artery or vein or directlythrough the heart; and bringing the circulatory support device to thesub-valvular position of the heart for circulatory support.
 21. A methodto implant a left or right ventricular circulatory support device ofclaim 1 in a sub-valvular position of an outlet valve of a respectiveventricle using endovascular over-the-wire techniques comprising:accessing a vascular system or directly the heart at one or two separatepoints to allow control of a guide wire at both ends for precise devicecontrol for exact deployment at a desired landing point in thesub-valvular position.
 22. Method as claimed in claim 21 furthercomprising adjusting and correcting of the circulatory support deviceposition with the step of applying traction on the wires in oppositedirection, wherein traction on both ends of the wires allows partialcollapse of the circulatory support device.
 23. A method of sealing andhemostasis of an access puncture site of the heart or vascular systemwith a driveline of the circulatory support device of claim 1, which hasa larger diameter than an access catheter used for a procedure forpositioning the circulatory support device in a ventricle comprising thestep of pulling a driveline out over a wire and sealing avascular/cardiac access site with the driveline.